ErythemaPhase 1CIPTNCT06369675
Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
A Phase 1 study testing MOB015B, 0.2% SLS and 0.9% Saline in people with Erythema, run by Moberg Pharma AB at 1 site in United States.
Trial summary
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- MOB015B, 0.2% SLS and 0.9% Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 14 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied prior to randomization:
- Is a healthy male or female (to be confirmed by medical history);
- Is 18 years of age or older;
- In the case of a female of childbearing potential, is using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
- Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
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- Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema
- Complete a medical screening procedure; and
- Read, understand, and sign an informed consent.
Who cannot join
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
- Has psoriasis and/or active atopic dermatitis/eczema;
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- Has a known sensitivity or allergy to constituents of the materials being evaluated;
- Is a female who is pregnant, plan to become pregnant during the study, or is breast feeding a child;
- Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- Has received treatment for any type of internal cancer within 5 years prior to study entry;
- Has a history of, or are currently being treated for skin cancer and/or hepatitis;
- Has a history of, or is currently being treated for, insulin dependent diabetes;
- Has any condition that might compromise study results;
- Currently or expect to sunbathe or use tanning salons during the study;
- Is currently participating in any clinical testing;
- Has any known sensitivity to adhesives; and/or
- Has received any investigational drug(s) within 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study
Read the detailed description
MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. A This study investigates the irritation potential of MOB015B under standardized conditions compared with a known irritant (0.2% SLS) and an inert control (normal saline). Because MOB015B is formulated for topical use, it is necessary to determine the potential of this product to cause irritation after repeated topical application to the skin.
- Conditions
- Erythema
- Being tested
- MOB015B, 0.2% SLS, 0.9% Saline, MOB015B vehicle
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015BDrug
Topical formulation
0.2% SLSDrug
Positive control
0.9% SalineDrug
Negative control
MOB015B vehicleDrug
Topical formulation
| Study group | Role | What they receive |
|---|---|---|
| MOB015B, MOB015B vehicle, 0.2% SLS and an inert control | Experimental | All subjects will receive MOB015B, MOB015B vehicle, 0.2% SLS (positive control) and inert control (negative control) Each subject will serve as his or her own control Receives: Drug: MOB015B; Drug: 0.2% SLS; Drug: 0.9% Saline; Drug: MOB015B vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions.
The mean cumulative irritation score
Measured: 22 days
To assess safety
Safety was assessed by evaluation of any AEs reported during the study.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Oct 2017
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dosik, MD, Principal investigator, TKL Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369675
- Sponsor's protocol ID
- MOB015B-V
- Acronym
- CIPT
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
- ClinicalTrials.gov ID
- NCT06369675
- Acronym / sponsor ID
- CIPT / MOB015B-V
- Conditions
- Erythema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study
Detailed description
MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. A This study investigates the irritation potential of MOB015B under standardized conditions compared with a known irritant (0.2% SLS) and an inert control (normal saline). Because MOB015B is formulated for topical use, it is necessary to determine the potential of this product to cause irritation after repeated topical application to the skin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOB015B, MOB015B vehicle, 0.2% SLS and an inert control | Experimental | Drug: MOB015B, Drug: 0.2% SLS, Drug: 0.9% Saline, Drug: MOB015B vehicleAll subjects will receive MOB015B, MOB015B vehicle, 0.2% SLS (positive control) and inert control (negative control) Each subject will serve as his or her own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A subject will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied prior to randomization:
- Is a healthy male or female (to be confirmed by medical history);
- Is 18 years of age or older;
- In the case of a female of childbearing potential, is using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
Key exclusion criteria (17 listed)
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOB015BTopical formulation | Drug | MOB015B, MOB015B vehicle, 0.2% SLS and an inert control |
| 0.2% SLSPositive control | Drug | MOB015B, MOB015B vehicle, 0.2% SLS and an inert control |
| 0.9% SalineNegative control | Drug | MOB015B, MOB015B vehicle, 0.2% SLS and an inert control |
| MOB015B vehicleTopical formulation | Drug | MOB015B, MOB015B vehicle, 0.2% SLS and an inert control |
Primary outcome
To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions.
Time frame: 22 days
The mean cumulative irritation score
To assess safety
Time frame: 22 days
Safety was assessed by evaluation of any AEs reported during the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Dosik, MD principal investigator
TKL Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MOB015B, 0.2% SLS and 0.9% Saline in people with Erythema, run by Moberg Pharma AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions. (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.